Oral Care Compositions Containing Potassium Nitrate and Peroxide

ABSTRACT

An oral care composition containing a gel phase, potassium nitrate, a peroxide source, an abrasive, and a fluoride source. Phase separation is not visually perceptible in the oral care composition.

FIELD OF THE INVENTION

The present invention relates to an oral care composition. Moreparticularly a stable toothpaste composition containing potassiumnitrate and peroxide.

BACKGROUND OF THE INVENTION

Oral care compositions, including toothpaste compositions, can containfluoride salts, abrasives, and flavors to clean teeth, freshen breath,and maintain the aesthetics and health of the oral cavity, including theteeth and gums. It can also be desirable to include potassium nitrate(KNO₃) in oral care compositions to help reduce pain from sensitiveteeth (dentinal hypersensitivity) and a peroxide, like hydrogenperoxide, to help whiten teeth.

However, formulating toothpaste compositions with the proper stabilityand rheology can be very challenging, especially when the compositioncontains peroxide and potassium nitrate. First, alkali metal salts, likepotassium nitrate, catalyze the hydrolysis of peroxide. When peroxidebreaks down, it forms oxygen, water, and radicals. The excess gas cancause swelling and bursting of primary packaging and the radicals cancause the entire oral care composition, including the actives andflavors, to break down to a composition with a water like viscosity withdecreased efficacy. Furthermore, unacceptable phase separation has beenobserved in certain toothpastes that KNO₃.

As such, there is a need for an improved oral care composition that isstable, has acceptable rheology, and contains peroxide and potassiumnitrate.

SUMMARY OF THE INVENTION

An oral care composition comprising: (a) a gel network phase comprisinga fatty amphiphile and a secondary surfactant; (b) potassium nitrate;(c) a peroxide source selected from the group consisting of hydrogenperoxide, urea peroxide, calcium peroxide, sodium peroxide, zincperoxide, polyvinylpyrrolidone peroxide complex or combinations thereof;(d) an abrasive; (e) a fluoride ion source selected from the groupconsisting of stannous fluoride, sodium fluoride, potassium fluoride,amine fluoride, sodium monofluorophosphate, indium fluoride, aminefluoride, and combinations thereof; wherein phase separation is notvisually perceptible as determined by the phase separation method.

An oral care composition comprising: (a) a gel network phase comprisinga cold dispersible fatty amphiphile; (b) potassium nitrate; (c) aperoxide source selected from the group consisting of hydrogen peroxide,urea peroxide, calcium peroxide, sodium peroxide, zinc peroxide,polyvinylpyrrolidone peroxide complex or combinations thereof; (d) anabrasive; and a fluoride ion source selected from the group consistingof stannous fluoride, sodium fluoride, potassium fluoride, aminefluoride, sodium monofluorophosphate, indium fluoride, amine fluoride,and combinations thereof; wherein the oral care composition comprisesfrom about 3% to about 17% fatty amphiphile; and wherein phaseseparation is not visually perceptible as determined by the phaseseparation method.

DETAILED DESCRIPTION OF THE INVENTION

Oral care compositions can include fluoride, peroxide, potassiumnitrate, abrasives, flavors, and other ingredients to provide benefitslike reducing plaque and tartar, reducing pain from sensitive teeth,preventing cavities, preventing and reversing gingivitis, buildingprotection against sensitivity, freshening bad breath, and whiteningteeth. Some consumers are particularly interested in a product thatcontains both potassium nitrate to help alleviate dentinalhypersensitivity and peroxide to help whiten teeth.

However, formulating toothpaste compositions with peroxide and potassiumnitrate can be challenging because many metals, like potassium nitrate,can catalyze hydrolysis of peroxide. Peroxide can also be incompatiblewith other compositions frequently found in oral care products, such asprecipitated silica abrasives and certain polymers. When peroxide breaksdown, it forms oxygen, water, and radicals. The excess gas can causeswelling and bursting of primary packaging and the radicals can causethe entire oral care composition, including the actives and flavors, tobreak down to a composition with a water like viscosity with decreasedefficacy.

In order to improve rheology, oral care products can include a gelnetwork phase as a structurant. The gel network phase can include afatty amphiphile, such as a fatty alcohol, and a secondary surfactant.Including a gel network phase can also provide a unique brushingexperience. For instance, toothpaste that contains a gel network phasecan have excellent foaming and the foam may not easily break down duringbrushing, even when it is used with an electric toothbrush. Also, somecommercially available toothpastes can feel harsh and can irritate auser's mouth, however, toothpastes containing gel networks can feelsmooth and are generally non-irritating. Additionally, after brushing,the mouth not only feels fresh and clean, but a user's teeth can feelespecially smooth and the smoothness can persist throughout the daybecause the amount of biofilm that builds on the teeth between brushingscan be significantly reduced.

However, it has been observed that toothpastes containing a gel networkphase and an effective level of KNO₃ can separate into phases, where thewater separates from the gel/paste phase, which is unacceptable. Whilenot wishing to be bound by theory, it is hypothesized that the saltinterrupts the structure of the gel network, which results in the phaseseparation. Phase separation in toothpaste is particularly problematic,as toothpaste is generally dispensed from a narrow tube with a smallopening, which makes it very difficult for a consumer to stir orotherwise mix the toothpaste to reincorporate the separated phase.

The toothpaste composition can contain a gel network phase, greater thanabout 1% hydrogen peroxide, an effective amount of potassium nitrate, afatty amphiphile, and a secondary surfactant. The toothpaste compositioncan also contain a peroxide stable polymer, including but not limited toa polymer containing 2-acrylamido-2-methylpropane sulfonic acid (AMPS)polymers, copolymers and crosspolymers. The toothpaste composition canalso contain an abrasive polishing material that is compatible withperoxide. The abrasive polishing material can be selected from the groupconsisting of polyorganosilsequioxane particles, calcium pyrophosphate,dicalcium phosphosphate, calcium phosphate, strontium carbonate, bariumsulfate, fused silica, or combinations thereof. The abrasive polishingmaterial is substantially free (i.e., less than 0.1 wt %, or less than0.05 wt %, or less than 0.01 wt %, or no detectable amounts of thosematerials) of precipitated silica.

The toothpaste composition can be phase stable and phase separation maynot be visually perceptible, as determined by the Phase SeparationMethod, described hereafter.

The composition may not have a visually perceptible phase separation.The term “visually perceptible” as used herein means that a human viewercan visually discern a phase separation with the unaided eye (exceptingstandard corrective lenses adapted to compensate for near-sightedness,farsightedness, or stigmatism, or other corrected vision) in lighting atleast equal to the illumination of a standard 100 watt incandescentwhite light bulb at a distance of approximately 18 inches.

All percentages and ratios used hereinafter are by weight of totalcomposition, unless otherwise indicated. All percentages, ratios, andlevels of ingredients referred to herein are based on the actual amountof the ingredient, and do not include solvents, fillers, or othermaterials with which the ingredient may be combined as a commerciallyavailable product, unless otherwise indicated.

All measurements referred to herein are made at 25° C. (i.e. roomtemperature) unless otherwise specified.

The composition can contain, consist of, or consist essentially of, theessential elements and limitations of the invention described herein, aswell as any additional or optional ingredients, components, orlimitations described herein or otherwise useful in oral carecompositions.

As used herein, the word “include,” and its variants, are intended to benon-limiting, such that recitation of items in a list is not to theexclusion of other like items that may also be useful in the materials,compositions, devices, and methods of this invention.

As used herein, the articles “a” and “an” are understood to mean one ormore of the material that is claimed or described, for example, “anabrasive” or “a surfactant”.

As used herein, the word “or” when used as a connector of two or moreelements is meant to include the elements individually and incombination; for example X or Y, means X or Y or both.

By “oral care composition”, as used herein, is meant a product, which inthe ordinary course of usage, is not intentionally swallowed forpurposes of systemic administration of particular therapeutic agents,but is rather retained in the oral cavity for a time sufficient tocontact dental surfaces or oral tissues. The oral care compositions caninclude toothpaste, mouth rinse, mousse, foam, mouth spray, lozenge,chewable tablet, chewing gum, tooth whitening strips, floss and flosscoatings, breath freshening dissolvable strips, or denture care oradhesive product. The oral care composition may also be incorporatedonto strips or films for direct application or attachment to oralsurfaces.

The term “dispenser”, as used herein, means any pump, tube, or containersuitable for dispensing compositions such as toothpastes.

The term “effective amount or “effective level” as used herein means anamount of a compound or composition sufficient to induce a positivebenefit, an oral health benefit, and/or an amount low enough to avoidserious side effects, i.e., to provide a reasonable benefit to riskratio, within the sound judgment of a skilled artisan. An “effectiveamount” can mean that at least 0.01% of the material, by weight of thecomposition, alternatively at least 0.1%. An “effective level” ofpotassium nitrate can be about 5%.

The term “secondary surfactant” as used herein means a surfactant otherthan a fatty amphiphile. Various types of suitable surfactants arelisted below. There may be more than one secondary surfactants. Therecan be at least one secondary surfactant in the gel network phase andthere may be another surfactant in the oral carrier phase.

The term “teeth”, as used herein, refers to natural teeth as well asartificial teeth or dental prosthesis.

The term “toothpaste”, as used herein, includes tooth or subgingivalpaste, gel, or liquid formulations unless otherwise specified. Thetoothpaste composition may be a single phase composition or may be acombination of two or more separate toothpaste compositions. Thetoothpaste composition may be in any desired form, such as deep striped,surface striped, multilayered, having a gel surrounding a paste, or anycombination thereof. Each toothpaste composition in a toothpastecomprising two or more separate toothpaste compositions may be containedin a physically separated compartment of a dispenser and dispensedside-by-side. As Herein, the terms “toothpaste” and “dentifrice” can beused interchangeably.

The term “water”, as used herein, refers to deionized water, unlessotherwise specified.

The term “water soluble” as used herein means that the material issoluble in water in the present composition. In general, the materialshould be soluble at 25° C. at a concentration of 0.1% by weight of thewater solvent, preferably at 1%, more preferably at 5%, more preferablyat 15%.

The toothpaste composition can include a gel network in combination withan effective level of KNO₃ and at least 1% peroxide. When formulating atoothpaste, it is important that the toothpaste has the proper rheology,so it is acceptable to consumers. The composition must not be too thickso it can easily dispense out of a tube but thick enough to stand up ona toothbrush without sinking into the bristles. Also, many consumersrinse the toothbrush after applying a nurdle of toothpaste and thenurdle cannot wash away when the water is applied from a faucet. Theviscosity of the oral composition must remain stable over time as not tocontinue to thicken so the oral composition remains easy to dispenseduring the shelf life. Once dispensed from a container, the oralcomposition should not be stringy or sticky as to be messy for aconsumer to use. The oral composition must also easily disperse once inthe mouth and foam. It is also desired that the oral composition notstick to a sink or leave difficult to remove residue. In addition tobalancing the viscosity and shear thinning to formulate acceptablerheology, the oral composition must also keep active ingredientsincluding fluoride salts, potassium nitrate stable, and peroxide stableand available so the product is efficacious.

It can be desirable to formulate the composition with a gel networkphase, in order to improve rheology, mouthfeel, and possibly stabilityof actives. However, when the composition contains both KNO₃ andperoxide, the gel network can be carefully formulated, since KNO₃ cancatalyze the hydrolysis of peroxide and synresis has been observed withgel networks toothpastes containing KNO₃.

The amount of fatty amphilphile and/or the amount of secondarysurfactant can be increased to improve phase stability. As used herein,“fatty amphiphile” refers to a compound having a hydrophobic tail groupand a hydrophilic head group which does not make the compound watersoluble (immiscible), wherein the compound also has a net neutral chargeat the pH of the oral composition. The fatty amphiphile can be selectedfrom the group consisting of fatty alcohols, alkoxylated fatty alcohols,fatty phenols, alkoxylated fatty phenols, fatty amides, alkyoxylatedfatty amides, fatty amines, fatty alkylamidoalkylamines, fattyalkyoxyalted amines, fatty carbamates, fatty amine oxides, fatty acids,alkoxylated fatty acids, fatty diesters, fatty sorbitan esters, fattysugar esters, methyl glucoside esters, fatty glycol esters, mono, di-and tri-glycerides, polyglycerine fatty esters, alkyl glyceryl ethers,propylene glycol fatty acid esters, cholesterol, ceramides, fattysilicone waxes, fatty glucose amides, phospholipids, and combinationsthereof. Suitable fatty amphiphiles include a combination of cetylalcohol and stearyl alcohol. The fatty amphiphile can be a fattyalcohol.

The fatty amphiphile can be a fatty alcohol. The fatty amphiphiles caninclude a cetyl alcohol and/or stearyl alcohol. The oral carecompositions may contain a fatty amphiphile in an amount greater thanabout 10%, greater than about 11%, greater than about 13%, greater thanabout 14%, greater from about 14.5%, greater than about 15%, greaterthan about 15.5%, and/or in greater than about 16%. The oral carecomposition may contain a fatty amphiphile in an amount less than about40%, less than about 35%, less than about 30%, less than about 25%, lessthan about 22%, less than about 20%, less than about 19%, less thanabout 18%, and/or less than about 17%. The oral care composition maycontain a fatty amphiphile in an amount from about 3% to about 30%, fromabout 4% to about 28%, from about 5% to about 26%, in from about 7% toabout 25%, from about 8% to about 23%, from about 10% to about 21%, fromabout 12% to about 20%, from about 13% to about 19%, from about 14% toabout 18%, and/or from about 15% to about 17%.

The toothpaste can be phase stable and can contain a gel network phase,which can include a cold dispersible fatty amphiphile and thecomposition can contain less than about 14% fatty amphiphile.

It can be desirable to use less fatty amphiphile, since some consumersfind that if the fatty amphiphile level is too high, the toothpaste mayhave less desirable aesthetics include suboptimal taste and flavordisplay and a greasy feeling in the oral cavity and on the lips. Thetoothpaste can be phase stable and can contain a gel network phase, aneffective level of potassium nitrate, greater than about 1% peroxide,and the toothpaste can contain less than about 14% fatty amphiphiles.The oral care composition can contain a cold dispersible fattyamphiphile.

The composition can contain a cold dispersible fatty amphiphile. Thecomposition can contain from about 1% to about 20% cold dispersiblefatty amphiphile, from about 3% to about 17%, from about 5% to about15%, from about 7% to about 13%, from about 8% to about 12%, and/or fromabout 9% to about 11.5%. The composition can contain from about 0.1% toabout 5% cold dispersible fatty amphiphile, from about 0.5% to about 3%,from about 0.75% to about 2.5%, and from about 1% to about 2%. Thecomposition can contain greater than about 0.5% cold dispersible fattyamphiphile, greater than about 1%, greater than about 3%, greater thanabout 5%, greater than about 7%, greater than about 8%, and/or greaterthan about 9%.

The cold dispersible fatty amphiphile can have a melting point greaterthan about 10° C., greater than about 25° C., greater than about 30° C.,greater than about 35° C., greater than about 40° C., greater than about45° C., greater than about 55° C. The melting point of the colddispersible fatty amphiphile can be from about 20° C. to about 100° C.,from about 30° C. to about 90° C., from about 35° C. to about 85° C.,from about 40° C. to about 80° C., from about 45° C. to about 75° C.,from about 50° C. to about 70° C., from about 55° C. to about 65° C.,and/or from about 57° C. to about 67° C. Melting point can be determinedby USP (United States Pharmacopeia) Testing Method <741>, Class 1a,Apparatus I.

The cold dispersible fatty amphiphile can contain straight or branchedcarbon chains from about C8 to about C25 and from about C12 to aboutC22.

The cold dispersible fatty amphiphile can contain 40% cetyl alcohol, 40%stearyl alcohol, 10% sodium lauryl sulfate (SLS), and 10% sodiumacrylate/sodium acryloyl dimethyl taurate copolymer.

The cold dispersible fatty amphiphile can contain from about 40% toabout 98% fatty amphiphile, from about 50% to about 95% fattyamphiphile, in from about 60% to about 90% fatty amphiphile, from about70% to about 85% fatty amphiphile, and/or from about 75% to about 80%fatty amphiphile. The fatty amphiphile can be a fatty alcohol. The colddispersible fatty amphiphile can contain one fatty alcohol and/or fattyamphiphile, two different fatty alcohols and/or fatty amphiphile, threedifferent fatty alcohols and/or fatty amphiphile, four different fattyalcohols and/or fatty amphiphiles, and/or five or more different fattyalcohols and/or fatty amphiphiles. The cold dispersible fatty amphiphilecan contain a fatty alcohol selected from the group consisting of cetylalcohol, stearyl alcohol, and combinations thereof. The cold dispersiblefatty amphiphile can contain two fatty alcohols where the first fattyalcohol is cetyl alcohol and the second fatty alcohol is stearylalcohol. The ratio of first fatty amphiphile to second fatty amphiphilecan be about 1:5 to about 5:1, from about 1:4 to about 4:1, from about1:3 to about 3:1, from about 1:2 to about 2:1, and/or the ratio can beabout 1:1.

The cold dispersible fatty amphiphile can contain from about 1% to about40% surfactant, from about 5% to about 30%, from about 7% to about 20%,and/or from about 10% to about 15%. The surfactant can be an anionicsurfactant. The surfactant can be sodium lauryl sulfate.

The cold dispersible fatty amphiphile can contain from about 1% to about40% polymer, from about 5% to about 30%, from about 7% to about 20%,from about 8% to about 15%, i from about 9% to about 14%, from about 10%to about 12%. The polymer can be an anionic polymer. The polymer is anAMPS polymer, which can have the following structure:

The polymer can be a polymer containing the following monomer unit:

where R₁ is independently selected from C₁ to C₄ (lower alkyls) andn=1-3.

The ratio of surfactant to polymer in the cold dispersible fattyamphiphile is about 1:10 to about 10:1, from about 1:7 to about 7:1,from about 1:5 to about 5:1, from about 1:3 to about 3:1, and the ratiocan be about about 1:1.

The ratio of fatty amphiphile to surfactant or polymer in the colddispersible fatty amphiphile can be from about 1:1 to about 30:1, fromabout 2:1 to 25:1, in from about 3:1 to about 20:1, from about 4:1 toabout 15:1, from about 5:1 to about 10:1, from about 6:1 to about 9:1,from about 7:1 to about 8:1, and/or about 8:1.

The ratio of fatty amphiphile to surfactant and polymer in the colddispersible fatty amphiphile can be 1:1 to 15:1, from about 2:1 to 10:1,from about 3:1 to about 8:1, from about 4:1 to about 6:1, and/or about4:1.

Since peroxide can be unstable, it may not be desirable to combineperoxide with particular polymers, including carrageenan. The oral carecomposition can be free of or substantially free of carrageenan. Thecomposition can be free of or substantially free of carboxymethylcellulose. The composition can be free of or substantially free ofxanthan gum. The composition can contain less than about 1%, less thanabout 0.5%, less than about 0.25%, less than about 0.1%, less than about0.05%, less than about 0.01%, less than about 0.001%, and/or less thanabout 0.0001% polymer selected from the group consisting of carrageenan,carboxymethyl cellulose, xanthan gum, and combinations thereof.

The oral care composition can contain an AMPS polymer, co-polymer,and/or crosspolymer, as described above. Non-limiting examples ofpolymers, copolymers and crosspolymers synthesized from AMPS can includehydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer(commercially available as Sepinov™ EMT-10 from SEPPIC S.A.), ammoniumacryloyldimethyl taurate/vinyl pyrrolidone copolymer (commerciallyavailable as Aristoflex® AVC from Clariant International LTD, Muttenz,Switzerland), ammonium acryloyldimethyltaurate/beheneth-25 methacrylatecrosspolymer (commercially available as Aristoflex® HMB, ClariantInternational LTD), sodium acrylate/sodium acryloyldimethyltauratecopolymer (a component of Sepigel EG and Simulgel SMS 88, SEPPIC S.A.),acrylamide/sodium acryloyldimethyltaurate copolymer (a component ofSimulgel 600 and Simulgel 600 PHA, SEPPIC S.A.), polyacrylatecrosspolymer-6 (commercially available as SepiMAX™ ZEN from SEPPICS.A.), and combinations thereof.

The oral care composition can contain polyacrylate crosspolymer-6(commercially available as SepiMAX™ ZEN from SEPPIC S.A., a subsidiaryof the Air Liquide group, Puteaux Cedex, France). The molecularstructure of polyacrylate crosspolymer-6 is shown below.

Polyacrylate crosspolymer-6 is a copolymer of Ammonium2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate, N,N,Dimethyl-2-acrylamide, Poly(oxy-1,2-ethanediyl),alpha-(2-methyl-1-oxo-2-propenyl0-omega-(dodecyloxy) andMethyl-2-propenoic acid dodecyl ester monomers.

The oral care composition can contain from about 0.1% to about 10% AMPSpolymer, copolymer, or crosspolymer, from about 0.5% to about 7%, fromabout 1% to about 5%, from about 1.2% to about 4%, and/or from about1.6% to about 3.5%. The oral care composition can contain from about0.01% to about 5% AMPS polymer, copolymer, or crosspolymer, from about0.1% to about 3%, from about 0.25% to about 1.5%, from about 0.3% toabout 1%, and/or in from about 0.5% to about 0.8%.

The composition can contain another salt, for instance pyrophosphates,which can help control tartar, in addition to or instead of potassiumnitrate.

Toothpastes that contain both gel networks, KNO₃, and peroxide can beenjoyed by consumers. They are used the same way as regular toothpaste.For instance, the American Dental Association recommends brushing atleast twice a day for two minutes with a soft-bristled brush. Then thebrush is placed in a user's mouth at a 45-degree angle to the gums andgently moved back and forth in short (tooth-wide) strokes. The outersurfaces, inner surfaces, and the chewing surfaces of the teeth can bebrushed. A user can also brush her tongue to remove bacteria and keepher breath fresh. The toothpaste containing gel networks can be combinedwith other oral care regiments such as flossing, mouthwashes, whiteningregimens, and regular visits to the dentist for professional cleaningsand oral exams.

The user can dispense the toothpaste from the container, which can be ametal or plastic tube. When dispensed, the first thing that a consumermay notice is the rheology of the toothpaste containing a gel network.The toothpaste can easily dispense from the container. The toothpastecan dispense cleanly out of the container onto the brush without beingstringy. The nurdle can be smooth, not lumpy, and is thick enough thatit stands up on the brush without sinking into the bristles.

Next, the consumer will brush her teeth. She may find that thetoothpaste feels especially smooth in her mouth and the toothpaste isnot irritating. Again, she may notice that the toothpaste is notstringy, but it is easily spread throughout her entire mouth. The usermay notice that the toothpaste foams. The foaming can feel unique, as itbuilds and/or is maintained during brushing, which can last two minutes(as recommended by the American Dental Association®) or longer. The foamis not dense and heavy, like some products that may overwhelm theconsumer. Furthermore, users may notice that foam from some currentcommercially available toothpastes breaks down and becomes thin andwatery and causes a mess during brushing, especially if the user isbrushing with an electric toothbrush. However, in toothpaste thatcontains a gel network phase, the foam can gently build during brushingand be very pleasant. Users may also notice that the flavor pleasantlybuilds intensity during brushing. After expectorating the toothpastecontaining a gel network, the user may find it easily removed from thesink, for instance in the toothpaste can be removed by simply turning onthe water for the sink. The toothpaste containing gel networks may notstain the sink or countertop or the user's mouth or lips.

Consumers may find that these desirable properties are maintained orsubstantially maintained for the entire shelf life of the product. Theoral care composition may not significantly thicken during the shelflife. The actives, including the fluoride component and the KNO₃ and/orperoxide, can be relatively stable and present at effective levels atthe end of the shelf life. The toothpaste can also keep the activesavailable so they can deliver a therapeutic effect while brushing.

After use, a consumer may find that her teeth feel especially smooth andshe may notice that this smoothness lasts for hours or even throughoutthe entire time between brushing. It may be determined that less biofilmforms over her teeth between brushing and consequently and thereforeusers of this product may have less plaque buildup over time. Afterusing the toothpaste containing gel networks for some time (even a shortperiod of time, such as a few brushings), a user may find that her gumsare less sensitive and may have reduced bleeding. A user may also havemore pleasant dental checkups because less plaque needs to be removedand her gums are not as sensitive. The user may believe that her teethlook especially white as well and the teeth may become whiter either byremoving extrinsic stains or intrinsically whitening teeth. The user mayhave a fresh clean feeling in her mouth for an extended period of time.The user may have fresh breath for an extended period of time. The usermay notice that her teeth are less sensitive.

The toothpaste composition has a shelf life of at least about 1 year, atleast about 1.5 years, at least about 2 years, at least about 2.5 years,and/or at least about 3 years.

The oral care composition can contain one or more secondary surfactants.The secondary surfactant is typically water soluble or miscible in thesolvent or oral carrier. Suitable secondary surfactants include anionic,zwitterionic, amphoteric, cationic, and nonionic secondary surfactants.The anionic secondary surfactants such as sodium lauryl sulfate, can beused. The composition can contain from about 1% to about 15% anionicsecondary surfactant, from about 2% to about 10%, from about 3% to about8.5%, from about 4% to about 8%, from 5% to about 7.5%, and/or fromabout 6% to about 7%. The secondary surfactants may be a combination ofmore than one type of secondary surfactants, such as an anionic andnonionic secondary surfactant. Suitable solvents for the presentinvention can include water, edible polyhydric alcohols such asglycerin, diglycerin, triglycerin, sorbitol, xylitol, butylene glycol,erythritol, polyethylene glycol, propylene glycol, and combinationsthereof.

Secondary surfactants may include anionic surfactants such asorganophosphate, which include alkyl phosphates. These surface activeorganophosphate agents have a strong affinity for enamel surface andhave sufficient surface binding propensity to desorb pellicle proteinsand remain affixed to enamel surfaces. Suitable examples oforganophosphate compounds include mono-, di- or triesters represented bythe general structure below wherein Z1, Z2, or Z3 may be identical ordifferent, at least one being an organic moiety, in one example selectedfrom linear or branched, alkyl or alkenyl group of from 1 to 22 carbonatoms, optionally substituted by one or more phosphate groups;alkoxylated alkyl or alkenyl, (poly)saccharide, polyol or polyethergroup.

Some other organophosphate agents include alkyl or alkenyl phosphateesters represented by the following structure:

wherein R1 represents a linear or branched, alkyl or alkenyl group offrom 6 to 22 carbon atoms, optionally substituted by one or morephosphate groups; n and m, are individually and separately, 2 to 4, anda and b, individually and separately, are 0 to 20; Z2 and Z3 may beidentical or different, each represents hydrogen, alkali metal,ammonium, protonated alkyl amine or protonated functional alkyl aminesuch as an alkanolamine, or a R1-(OCnH2n)a(OCmH2m)b-group. Examples ofsuitable agents include alkyl and alkyl (poly)alkoxy phosphates such aslauryl phosphate; PPG5 ceteareth-10 phosphate; Laureth-1 phosphate;Laureth-3 phosphate; Laureth-9 phosphate; Trilaureth-4 phosphate; C12-18PEG 9 phosphate; Sodium dilaureth-10 phosphate. The alkyl phosphate ispolymeric. Polymeric alkyl phosphates can include those containingrepeating alkoxy groups as the polymeric portion, in particular 3 ormore ethoxy, propoxy isopropoxy or butoxy groups.

Zwitterionic or amphoteric secondary surfactants useful in the presentinvention can include derivatives of aliphatic quaternary ammonium,phosphonium, and sulfonium compounds, in which the aliphatic radicalscan be straight chain or branched, and wherein one of the aliphaticsubstituents contains from about 8 to 18 carbon atoms and one containsan anionic water-solubilizing group, such as carboxy, sulfonate,sulfate, phosphate or phosphonate. Suitable amphoteric secondarysurfactants include betaine surfactants such as disclosed in U.S. Pat.No. 5,180,577 to Polefka et al. Typical alkyl dimethyl betaines includedecyl betaine or 2-(N-decyl-N,N-dimethylammonio) acetate, coco betaineor 2-(N-coco-N, N-dimethyl ammonio) acetate, myristyl betaine, palmitylbetaine, lauryl betaine, cetyl betaine, stearyl betaine, etc. Amphotericsurfactants useful herein further include amine oxide surfactants. Theamidobetaines are exemplified by cocoamidoethyl betaine, cocamidopropylbetaine (CAPB), and lauramidopropyl betaine. The unwanted tastes oftenassociated with these secondary surfactants are soapy, bitter, chemical,or artificial. The composition can contain from about 0.1% to about 6%amphoteric secondary surfactant, from about 0.5% to about 4%, from about0.75% to about 2%, and/or about 1%.

Additional suitable polymeric organophosphate agents can include dextranphosphate, polyglucoside phosphate, alkyl polyglucoside phosphate,polyglyceryl phosphate, alkyl polyglyceryl phosphate, polyetherphosphates and alkoxylated polyol phosphates. Some specific examples arePEG phosphate, PPG phosphate, alkyl PPG phosphate, PEG/PPG phosphate,alkyl PEG/PPG phosphate, PEG/PPG/PEG phosphate, dipropylene glycolphosphate, PEG glyceryl phosphate, PBG (polybutylene glycol) phosphate,PEG cyclodextrin phosphate, PEG sorbitan phosphate, PEG alkyl sorbitanphosphate, and PEG methyl glucoside phosphate. Suitable non-polymericphosphates include alkyl mono glyceride phosphate, alkyl sorbitanphosphate, alkyl methyl glucoside phosphate, alkyl sucrose phosphates.The impurities in these phosphates may induce a burning sensation.Impurities may include dodecanol, dodecanal, benzaldehyde, and otherTRPA1 or TRPV1 agonists.

Cationic secondary surfactants useful in the present invention caninclude derivatives of quaternary ammonium compounds having one longalkyl chain containing from about 8 to 18 carbon atoms such as lauryltrimethylammonium chloride, cetyl trimethylammonium bromide, coconutalkyltrimethylammonium nitrite, cetyl pyridinium fluoride, etc.Quaternary ammonium halides having detergent properties can be used,such as those described in U.S. Pat. No. 3,535,421 to Briner et al.Certain cationic secondary surfactants can also act as germicides in theoral care compositions disclosed herein.

The oral care composition can have a viscosity from about 5 BKUs toabout 70 BKUs, from about 10 BKUs to about 45 BKUs, from about 12 BKUsto about 40 BKUs, from about 15 BKUs to about 35 BKUs, from about 18BKUs to about 30 BKUs, from about 20 BKUs to about 28 BKUs, and/or fromabout 22 BKUs to about 25 BKUs. The oral care compositions can have aviscosity from about 10 BKUs to about 200 BKUs, from about 20 BKUs toabout 175 BKUs from about 30 BKUs to about 150 BKUs, and/or from about50 BKUs to 100 BKUs. The oral care compositions can have a viscosityfrom about 10 BKUs to about 200 BKUs, from about 20 BKUs to about 175BKUs from about 30 BKUs to about 150 BKUs, and/or from about 50 BKUs to100 BKUs. Viscosity can measured by the Brookfield Viscosity Test asdescribed hereafter.

The oral care composition can have a shelf life, when stored below 40°C., of at least 6 months, at least 1 year, at least 18 months, at least2 years, at least 30 months, and/or in at least 3 years. The shelf lifecan be from about 6 months to about 5 years, from about 1 year to about3 years, and/or from about 1.5 years to about 2.5 years.

The oral care composition can have a pH from about 2 to about 10, fromabout 4 to about 9, from about 5 to about 8, and/or from about 6 toabout 7.5. pH can be measured using the pH Test Method as describedhereafter.

Actives and other ingredients may be categorized or described herein bytheir cosmetic benefit, therapeutic benefit, or their postulated mode ofaction or function. However, it is to be understood that the active andother ingredients useful herein can, in some instances, provide morethan one cosmetic benefit, therapeutic benefit, function, or can operatevia more than one mode of action. Therefore, classifications herein aremade for the sake of convenience and are not intended to limit aningredient to the particularly stated function(s) or activities listed.

It is common to have a fluoride compound present in toothpastes andother oral care compositions in an amount sufficient to give a fluorideion concentration in the composition of from about 0.0025% to about 5.0%or from about 0.005% to about 2.0%, by weight of the oral carecomposition to provide anticaries effectiveness. A wide variety offluoride ion-yielding materials can be employed as sources of solublefluoride in the present invention. Representative fluoride ion sourcesinclude: stannous fluoride, sodium fluoride, potassium fluoride, aminefluoride, sodium monofluorophosphate, indium fluoride, amine fluoridessuch as Olaflur, and many others. Examples of suitable fluorideion-yielding materials are found in U.S. Pat. No. 3,535,421 to Briner etal. and U.S. Pat. No. 3,678,154 to Widder et al.

A metal salt includes zinc salts, stannous salts, potassium salts,copper salts, alkali metal bicarbonate slats, and combinations thereof.Metal salts have a wide range of functions from antimicrobial agents tosensitivity agents or buffers. The oral care compositions of the presentinvention may contain metal salt in an amount from about 0.05% to about11%, from about 0.5% to about 7%, or from about 1% to about 5%, by totalweight of the oral care composition. Some metal salts which may be usedin the present invention, such as zinc chloride, zinc citrate, coppergluconate, and zinc gluconate, are also associated with an off tastedescribed as dirty, dry, earthy, metallic, sour, bitter, and astringent.

Stannous salts include stannous fluoride, stannous chloride, stannousiodide, stannous chlorofluoride, stannous actetate, stannoushexafluorozirconate, stannous sulfate, stannous lactate, stannoustartrate, stannous gluconate, stannous citrate, stannous malate,stannous glycinate, stannous pyrophosphate, stannous metaphosphate,stannous oxalate, stannous phosphate, stannous carbonate, andcombinations thereof. Dentifrices containing stannous salts,particularly stannous fluoride and stannous chloride, are described inU.S. Pat. No. 5,004,597 to Majeti et al. Other descriptions of stannoussalts are found in U.S. Pat. No. 5,578,293 issued to Prencipe et al. andin U.S. Pat. No. 5,281,410 issued to Lukacovic et al. In addition to thestannous ion source, other ingredients used to stabilize the stannousmay be included, such as the ingredients described in Majeti et al. andPrencipe et al.

Zinc salts include zinc fluoride, zinc chloride, zinc iodide, zincchlorofluoride, zinc actetate, zinc hexafluorozirconate, zinc sulfate,zinc lactate, zinc tartrate, zinc gluconate, zinc citrate, zinc malate,zinc glycinate, zinc pyrophosphate, zinc metaphosphate, zinc oxalate,zinc phosphate, zinc carbonate, and combinations thereof.

Potassium salts can include potassium nitrate, potassium citrate,potassium oxalate, potassium bicarbonate, potassium acetate, potassiumchloride, and combinations thereof. The composition can contain fromabout 0.05% to about 15% potassium nitrate, from about 0.5% to about10%, from about 1% to about 8%, from about 2% to about 7%, from about 3%to about 6%, and from about 4% to about 5.5%, by total weight of theoral care composition.

The copper salt can be selected from copper fluoride, copper chloride,copper iodide, copper chlorofluoride, copper actetate, copperhexafluorozirconate, copper sulfate, copper lactate, copper tartrate,copper gluconate, copper citrate, copper malate, copper glycinate,copper pyrophosphate, copper metaphosphate, copper oxalate, copperphosphate, copper carbonate, and combinations thereof. The copper saltcan be selected from copper gluconate, copper acetate, copper glycinate,and combinations thereof.

Sweeteners can include saccharin, chloro-sucrose (sucralose),steviolglycosides, rebaudioside A, rebaudioside B, rebaudioside C,rebaudioside D, rebaudioside E, rebaudioside F, dulcoside A, dulcosideB, rubusoside, stevia, stevioside, acesulfame K, xylitol, neohesperidineDC, alitame, aspartame, neotame, alitame, thaumatin, cyclamate,glycyrrhizin, mogroside IV, mogroside V, Luo Han Guo sweetener,siamenoside, monatin and its salts (monatin SS, RR, RS, SR), curculin,monellin, mabinlin, brazzein, hemandulcin, phyllodulcin, glycyphyllin,phloridzin, trilobatin, baiyanoside, osladin, polypodoside A,pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I,periandrin I, abrusoside A, cyclocariosideI,N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L-α-aspartyl]-L-phenylalanine1-methyl ester,N-[N-[3-(3-hydroxy-4-methoxyphenyl)-3-methylbutyl]-L-α-aspartyl]-L-phenylalanine1-methyl ester,N-[N-[3-(3-methoxy-4-hydroxyphenyl)propyl]-L-α-aspartyl]-L-phenylalanine1-methyl ester, salts thereof, and combinations thereof.

Rebiana can be a steviolglycoside from Cargill Corp., Minneapolis,Minn., which is an extract from the leaves of the Stevia rebaudianaplant (hereinafter referred to as “Rebiana”). This is a crystallinediterpene glycoside, about 300x sweeter than sucrose. Suitablestevioglycosides which may be combined can include rebaudioside A,rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside E,rebaudioside F, dulcoside A, dulcoside B, rubusoside, stevioside, orsteviolbioside. The combination of high-potency sweeteners can compriserebaudioside A in combination with rebaudioside B, rebaudioside C,rebaudioside F, rebaudioside F, stevioside, steviolbioside, dulcoside A.Sweeteners are generally included in an oral care composition at a levelof about 0.0005% to about 2%, by total weight of the oral carecomposition.

Carrier materials can include water, glycerin, sorbitol, polyethyleneglycols including those having a molecular weight of less than about50,000, propylene glycol and other edible polyhydric alcohols, ethanol,or combinations thereof. The oral care compositions of the presentinvention include from about 5% to about 80%, by weight of thecomposition, of a carrier material. The compositions can contain carriermaterials in an amount of from about 10% to about 40%, by total weightof the oral care composition.

The composition can contain from about 15% to about 95% water, fromabout 20% to about 85%, from about 25% to about 70%, from about 28% toabout 60%, from about 30% to about 50%, from about 31% to about 48%,from about 32% to about 45%, and/or from about 33% to about 43%. Thecomposition can contain from about 1% to about 20% water, from about 2%to about 15% water, from about 3% to about 10% water, and/or from about4% to about 8% water. The composition can contain greater than about 5%water, greater than about 8%, greater than about 10%, greater than about15%, greater than about 20%, greater than about 25%, greater than about30%, greater than about 40%, and/or greater than about 50%.

Antimicrobial agents include quaternary ammonium compounds. Those usefulin the present invention can include those in which one or two of thesubstitutes on the quaternary nitrogen has a carbon chain length(typically alkyl group) from about 8 to about 20, typically from about10 to about 18 carbon atoms while the remaining substitutes (typicallyalkyl or benzyl group) have a lower number of carbon atoms, such as fromabout 1 to about 7 carbon atoms, typically methyl or ethyl groups.Dodecyl trimethyl ammonium bromide, tetradecylpyridinium chloride,domiphen bromide, N-tetradecyl-4-ethyl pyridinium chloride, dodecyldimethyl (2-phenoxyethyl) ammonium bromide, benzyl dimethoylstearylammonium chloride, quaternized 5-amino-1,3-bis(2-ethyl-hexyl)-5-methylhexahydropyrimidine, benzalkonium chloride, benzethonium chloride andmethyl benzethonium chloride are exemplary of typical quaternaryammonium antibacterial agents.

Other quaternary ammonium compounds include the pyridinium compounds.Examples of pyridinium quaternary ammonium compounds can includebis[4-(R-amino)-1-pyridinium]alkanes as disclosed in U.S. Pat. No.4,206,215, Jun. 3, 1980, to Bailey and cetylpyridinium andtetradecylpyridinium halide salts (i.e., chloride, bromide, fluoride andiodide).

The oral care compositions of the present invention may also includeother antimicrobial agents including non-cationic antimicrobial agentssuch as halogenated diphenyl ethers, phenolic compounds including phenoland its homologs, mono and poly-alkyl and aromatic halophenols,resorcinol and its derivatives, xylitol, bisphenolic compounds andhalogenated salicylanilides, benzoic esters, and halogenatedcarbanilides. Also useful antimicrobials are enzymes, includingendoglycosidase, papain, dextranase, mutanase, and combinations thereof.Such agents are disclosed in U.S. Pat. No. 2,946,725, Jul. 26, 1960, toNorris et al. and in U.S. Pat. No. 4,051,234 to Gieske et al. Examplesof other antimicrobial agents can include chlorhexidine, and flavor oilssuch as thymol. The antimicrobial agent can include triclosan.

The compositions of the present invention may contain antimicrobialagents in an amount of from about 0.035% or more, from about 0.1% toabout 2.0%, from about 0.045% to about 1.0%, or from about 0.05% toabout 0.10%, by total weight of the oral care composition. Thecompositions can include from about 0.001% to about 1.5% antimicrobialagent, from about 0.005% to about 0.8%, from 0.01% to about 0.7%, fromabout 0.05% to about 0.5%, and/or from about 0.1% to about 0.3%.

Non-limiting examples of peroxide (peroxygen) compounds can includehydrogen peroxide, urea peroxide, calcium peroxide, sodium peroxide,zinc peroxide, polyvinylpyrrolidone peroxide complex or combinationsthereof. The composition can contain greater than about 0.05% peroxide,greater than about 0.5%, greater than about 0.75%, greater than about1%, greater than about 1.25%, greater than about 1.5%, greater thanabout 1.75%, greater than about 2%, greater than about 2.25%, greaterthan about 2.5%, greater than about 2.75%, greater than about 2.85%,greater than about 2.9%, greater than about 2.95%, greater than about3%, greater than about 4%, greater than about 5%, and greater than about6%. The composition can contain from about 0.01% to 10% peroxide, fromabout 0.05% to about 8%, from about 0.1% to about 5%, from about 0.5% toabout 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%,and/or from about 2% to about 3%. The composition can contain from about1% to about 10% peroxide, from about 2% to about 8% peroxide, from about3% to about 7% peroxide, and/or from about 4% to about 6% peroxide. Thecomposition can contain from about 0.01% to about 6% peroxide, fromabout 0.05% to about 3%, and/or from about 0.1% to about 1%.

The composition can be free of or substantially free of a peroxidecomponent, including but not limited to hydrogen peroxide.

The oral care composition can include bleaching agents. Bleaching agentscan include perborates, percarbonates, peroxyacids, persulfates,peracids, peracid precursor systems, and preformed peracids andcombinations thereof. One example of a percarbonate can include sodiumpercarbonate. An example of a persulfate can include oxones. Thecompositions of the present invention may contain bleaching agents in anamount of from about 0.01% to about 30%, from about 0.1% to about 10%,or from about 0.5% to about 5%, by total weight of the oral carecomposition.

Some flavors that may be used in oral care compositions are mint oils,and components thereof, wintergreen, clove bud oil, cassia, sage,parsley oil, marjoram, lemon, orange, propenyl guaethol, heliotropine,cis-4-heptenal, diacetyl, methyl-ρ-tert-butyl phenyl acetate, methylsalicylate, ethyl salicylate, 1-menthyl acetate, oxanone, α-irisone,methyl cinnamate, ethyl cinnamate, butyl cinnamate, ethyl butyrate,ethyl acetate, methyl anthranilate, iso-amyl acetate, iso-amyl butyrate,allyl caproate, eugenol, eucalyptol, thymol, cinnamic alcohol, octanol,octanal, decanol, decanal, phenylethyl alcohol, benzyl alcohol,α-terpineol, linalool, limonene, citral, neral, geranial, geraniolnerol, maltol, ethyl maltol, anethole, dihydroanethole, carvone,menthone, β-damascenone, ionone, γ-decalactone, γ-nonalactone,γ-undecalactone, isopulegol, piperitone, or combinations thereof.Generally suitable flavoring ingredients are chemicals with structuralfeatures and functional groups that are less prone to redox reactions.These include derivatives of flavor chemicals that are saturated orcontain stable aromatic rings or ester groups.

Flavors can be present in an amount of from about 0.4% to about 5%, bytotal weight of the oral care composition, alternatively from about 0.8%to about 4%, alternatively from about 1% to about 3.5%, andalternatively from about 1.5% to about 3%. It can be desirable to have aflavor composition at less than about 4%, by total weight of the oralcare composition, alternatively less than about 3.5%, alternatively inanother example less than about 3%, and alternatively less than about2%.

Dentifrice compositions of the present invention may also comprise ananti-calculus agent, which may be present from about 0.05% to about 50%,by weight of the dentifrice composition, alternatively from about 0.05%to about 25%, and alternatively from about 0.1% to about 15%. Thecompositions can contain an amount of anti-calculus agent that iseffective in tartar control effective. The amount of pyrophosphate saltmay be from about 1.5% to about 15%, alternatively from about 2% toabout 10%, or alternatively from about 3% to about 8%. The anti-calculusagent may be selected from the group consisting of polyphosphates(including pyrophosphates) and salts thereof; polyamino propane sulfonicacid (AMPS) and salts thereof; polyolefin sulfonates and salts thereof;polyvinyl phosphates and salts thereof; polyolefin phosphates and saltsthereof; diphosphonates and salts thereof; phosphonoalkane carboxylicacid and salts thereof; polyphosphonates and salts thereof; polyvinylphosphonates and salts thereof; polyolefin phosphonates and saltsthereof; polypeptides; and mixtures thereof. In one embodiment, thesalts are alkali metal salts. Polyphosphates are generally employed astheir wholly or partially neutralized water-soluble alkali metal saltssuch as potassium, sodium, ammonium salts, and mixtures thereof. Theinorganic polyphosphate salts include alkali metal (e.g. sodium)tripolyphosphate, tetrapolyphosphate, dialkyl metal (e.g. disodium)diacid, trialkyl metal (e.g. trisodium) monoacid, potassium hydrogenphosphate, sodium hydrogen phosphate, and alkali metal (e.g. sodium)hexametaphosphate, and mixtures thereof. The composition can containfrom about 1% to about 30% polyphosphate salts, alternatively from about5% to about 25%, alternatively from about 10% to about 20%,alternatively from about 11% to about 15%, and alternatively from about13%. Polyphosphates larger than tetrapolyphosphate usually occur asamorphous glassy materials. In one embodiment the polyphosphates arethose manufactured by FMC Corporation, which are commercially known asSodaphos (n≈6), Hexaphos (n≈13), and Glass H (n≈21, sodiumhexametaphosphate), and mixtures thereof. The pyrophosphate salts usefulin the present invention include, alkali metal pyrophosphates, di-,tri-, and mono-potassium or sodium pyrophosphates, dialkali metalpyrophosphate salts, tetraalkali metal pyrophosphate salts, and mixturesthereof. In one embodiment the pyrophosphate salt is selected from thegroup consisting of trisodium pyrophosphate, disodium dihydrogenpyrophosphate (Na₂H₂P₂O₇), dipotassium pyrophosphate, tetrasodiumpyrophosphate (Na₄P₂O₇), tetrapotassium pyrophosphate (K₄P₂O₇), andmixtures thereof. Polyolefin sulfonates include those wherein the olefingroup contains 2 or more carbon atoms, and salts thereof. Polyolefinphosphonates include those wherein the olefin group contains 2 or morecarbon atoms. Polyvinylphosphonates include polyvinylphosphonic acid.Diphosphonates and salts thereof include azocycloalkane-2,2-diphosphonicacids and salts thereof, ions of azocycloalkane-2,2-diphosphonic acidsand salts thereof, azacyclohexane-2,2-diphosphonic acid,azacyclopentane-2,2-diphosphonic acid,N-methyl-azacyclopentane-2,3-diphosphonic acid, EHDP(ethane-1-hydroxy-1,1,-diphosphonic acid), AHP(azacycloheptane-2,2-diphosphonic acid),ethane-1-amino-1,1-diphosphonate, dichloromethane-diphosphonate, etc.Phosphonoalkane carboxylic acid or their alkali metal salts include PPTA(phosphonopropane tricarboxylic acid), PBTA(phosphonobutane-1,2,4-tricarboxylic acid), each as acid or alkali metalsalts. Polyolefin phosphates include those wherein the olefin groupcontains 2 or more carbon atoms. Polypeptides include polyaspartic andpolyglutamic acids.

Some colorants that may be used in oral care compositions include D&CYellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 33 andcombinations thereof. The composition can comprise colorant in an amountof from about 0.0001% to about 0.1% or from about 0.001% to about 0.01%,by weight of the oral care composition. Some colorants provide anunwanted taste, for example, D&C Red No. 33. The unwanted tastes oftenassociated with this colorant are metallic, sharp, or chemical.Colorants are generally present in an amount of from about 0.001% toabout 0.5%, by weight of the oral care composition.

Sensates may also be part of an oral care composition. Sensate moleculessuch as cooling, warming, and tingling agents are useful to deliversignals to the user. Sensates are generally present in an amount of fromabout 0.001% to about 2%, by weight of the oral care composition. Themost well-known cooling sensate compound can be menthol, particularlyL-menthol, which is found naturally in peppermint and spearmint oilsnotably of Mentha piperita, Mentha arvensis L and Mentha viridis L.Other isomers of menthol (neomenthol, isomenthol and neoisomenthol) havesomewhat similar, but not identical odor and taste, for instance havingdisagreeable odor and taste described as earthy, camphor, musty, etc.The biggest difference among the isomers is in their cooling potency.L-menthol provides the most potent cooling, by having the lowest coolingthreshold of about 800 ppb, which is the concentration level where thecooling effect can be clearly recognized. At this level, there can be nocooling effect for the other isomers. For example, d-neomenthol isreported to have a cooling threshold of about 25,000 ppb and1-neomenthol about 3,000 ppb.

Of the menthol isomers the 1-isomer occurs most widely in nature and istypically what is referred by the name menthol having coolantproperties. L-menthol has the characteristic peppermint odor, has aclean fresh taste and exerts a cooling sensation when applied to theskin and mucosal surfaces.

Among synthetic coolants, many are derivatives of or are structurallyrelated to menthol, for example containing the cyclohexane moiety, andderivatized with functional groups including carboxamide, ketal, ester,ether and alcohol. Examples include the ρ-menthanecarboxamide compoundssuch as N-ethyl-ρ-menthan-3-carboxamide, known commercially as “WS-3”,and others in the series such as WS-5(N-ethoxycarbonylmethyl-ρ-menthan-3-carboxamide), WS-12 (1R*,2S*)-N-(4-Methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide]and WS-14 (N-tert-butyl-ρ-menthan-3-carboxamide). Examples of menthanecarboxy esters include WS-4 and WS-30. An example of a syntheticcarboxamide coolant that is structurally unrelated to menthol isN,2,3-trimethyl-2-isopropylbutanamide, known as “WS-23”. Additionalexamples of synthetic coolants include alcohol derivatives such as3-(1-menthoxy)-propane-1,2-diol known as TK-10, isopulegol (under thetradename Coolact P) and ρ-menthane-3,8-diol (under the tradenameCoolact 38D) all available from Takasago Corp., Tokyo, Japan; menthoneglycerol acetal known as MGA; menthyl esters such as menthyl acetate,menthyl acetoacetate, menthyl lactate known as Frescolat® supplied bySymrise AG, Holzminden, Germany, and monomenthyl succinate under thetradename Physcool from V. Mane FILS, Notre Dame, France. TK-10 isdescribed in U.S. Pat. No. 4,459,425 to Amano et al. Other alcohol andether derivatives of menthol are described in GB 1,315,626 and in U.S.Pat. Nos. 4,029,759; 5,608,119; and 6,956,139. WS-3 and othercarboxamide cooling agents are described in U.S. Pat. Nos. 4,136,163;4,150,052; 4,153,679; 4,157,384; 4,178,459 and 4,230,688.

Additional N-substituted p-menthane carboxamides are described in WO2005/049553A1 including N-(4-cyanomethylphenyl)-ρ-menthanecarboxamide,N-(4-sulfamoylphenyl)-ρ-menthanecarboxamide,N-(4-cyanophenyl)p-menthanecarboxamide,N-(4-acetylphenyl)-ρ-menthanecarboxamide,N-(4-hydroxymethylphenyl)-ρ-menthanecarboxamide andN-(3-hydroxy-4-methoxyphenyl)-ρ-menthanecarboxamide. Other N-substitutedρ-menthane carboxamides include amino acid derivatives such as thosedisclosed in WO 2006/103401 and in U.S. Pat. Nos. 4,136,163; 4,178,459and 7,189,760 such asN-((5-methyl-2-(1-methylethyl)cyclohexyl)carbonyl)glycine ethyl esterand N-((5-methyl-2-(1-methylethyl)cyclohexyl)carbonyl)alanine ethylester. Menthyl esters including those of amino acids such as glycine andalanine are disclosed e.g., in EP 310,299 and in U.S. Pat. Nos.3,917,613; 3,991,178; 5,703,123; 5,725,865; 5,843,466; 6,365,215; and6,884,903. Ketal derivatives are described, e.g., in U.S. Pat. Nos.5,266,592; 5,977,166; and 5,451,404. Additional agents that arestructurally unrelated to menthol but have been reported to have asimilar physiological cooling effect include alpha-keto enaminederivatives described in U.S. Pat. No. 6,592,884 including3-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (3-MPC),5-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (5 -MPC), and2,5-dimethyl-4-(1-pyrrolidinyl)-3(2H)-furanone (DMPF); icilin (alsoknown as AG-3-5, chemical name1-[2-hydroxyphenyl]-4-[2-nitrophenyl]-1,2,3,6-tetrahydropyrimidine-2-one)described in Wei et al., J. Pharm. Pharmacol. (1983), 35:110-112.Reviews on the coolant activity of menthol and synthetic coolantsinclude H. R. Watson, et al. J. Soc. Cosmet. Chem. (1978), 29, 185-200and R. Eccles, J. Pharm. Pharmacol., (1994), 46, 618-630 and phosphineoxides as reported in U.S. Pat. No. 4,070,496.

Some examples of warming sensates include ethanol; capsicum; nicotinateesters, such as benzyl nicotinate; polyhydric alcohols; capsicum powder;a capsicum tincture; capsicum extract; capsaicin; homocapsaicin;homodihydrocapsaicin; nonanoyl vanillyl amide; nonanoic acid vanillylether; vanillyl alcohol alkyl ether derivatives such as vanillyl ethylether, vanillyl butyl ether, vanillyl pentyl ether, and vanillyl hexylether; isovanillyl alcohol alkyl ethers; ethylvanillyl alcohol alkylethers; veratryl alcohol derivatives; substituted benzyl alcoholderivatives; substituted benzyl alcohol alkyl ethers; vanillin propyleneglycol acetal; ethylvanillin propylene glycol acetal; ginger extract;ginger oil; gingerol; zingerone; or combinations thereof. Warmingsensates are generally included in an oral care composition at a levelof about 0.05% to about 2%, by weight of the oral care composition.

The abrasive polishing material can have a BET surface area greater thanabout 5 m²/g, alternatively greater than about 10 m²/g, alternativelygreater than about 15 m²/g, in alternatively greater than about 18 m²/g,alternatively greater than about 25 m²/g, alternatively greater thanabout 30 m²/g, alternatively greater than about 35 m²/g, alternativelygreater than about 40 m²/g, and alternatively greater than about 50m²/g. The BET surface area of the abrasive polishing material can befrom about 5 m²/g to about 30 m²/g, alternatively from about 10 m²/g toabout 200 m²/g, alternatively from about 20 m²/g to about 150 m²/g,alternatively from about 25 m²/g to about 100 m²/g, alternatively fromabout 30 m²/g to about 75 m²/g, alternatively from about 35 m²/g toabout 60 m²/g, alternatively from about 38 m²/g to about 50 m²/g, andalternatively from about 40 m²/g to about 45 m²/g. The precipitatedsilica can have a BET surface area from about 19 m²/g to about 55 m²/gand alternatively from about 19 m²/g to about 35 m²/g. In The silica canhave a BET surface area from about 10 m²/g to about 80 m²/g,alternatively from about 20 m²/g to about 70 m²/g, alternatively fromabout 25 m²/g to about 50 m²/g, or alternatively from about 30 m²/g toabout 45 m²/g. BET surface area is determined by BET nitrogen absorptionmethod of Brunaur et al., J. Am. Chem. Soc., 60, 309 (1938). See alsoU.S. Pat. No. 7,255,852 to Gallis.

The abrasive polishing material can have an LOD of about 1% to about10%, in alternatively from about 3% to about 7%, alternatively fromabout 4% to about 6.75%, and alternatively from about 5.6% to about6.1%. The LOD is less than about 7%, alternatively less than about 6.5%,and alternatively less than about 6.25%. The abrasive polishing materialcan have an LOI from about 2% to about 10%, alternatively from about 3%to about 7%, alternatively from about 4% to about 6%, and alternativelyabout 5.1%. The LOI can be greater than about 3%, alternatively greaterthan about 4%, and alternatively greater than about 5%. The sum of LODand LOI can be from about 5% to about 20%, alternatively from about 7%to about 17%, alternatively from about 8% to about 15%, alternativelyfrom about 9% to about 14%, and alternatively from about 10% to about12.5%. Silicas with less than about 5% bound and free water may beconsidered substantially non-hydrated. The total bound and free watercan be calculated by totaling two measurements, loss on drying (LOD) andloss on ignition (LOI). For loss on drying, performed first, a samplemay be dried at 105° C. for two hours, the weight loss being the freewater. For loss on ignition, the dried sample then may be heated for onehour at 1000° C., the weight loss being the bound water. The sum of theLOD and LOI represents the total bound and free water in the originalsample.

Typical abrasive polishing materials can include silicas including gelsand precipitates; aluminas; phosphates including orthophosphates,polymetaphosphates, and pyrophosphates; and mixtures thereof. Specificexamples include silicone microspheres such as polyorganosilsesquioxaneparticles, dicalcium orthophosphate dihydrate, calcium pyrophosphate,tricalcium phosphate, calcium polymetaphosphate, insoluble sodiumpolymetaphosphate, rice hull silica, hydrated alumina, beta calciumpyrophosphate, calcium carbonate, and resinous abrasive materials suchas particulate condensation products of urea and formaldehyde, andothers such as disclosed by Cooley et al in U.S. Pat. No. 3,070,510. Incertain examples, if the oral composition or particular phase comprisesa polyphosphate having an average chain length of about 4 or more,calcium containing abrasives and alumina are not preferred abrasives. Incertain examples, the composition is substantially free of silica.

The composition can contain a silica abrasive. Silica abrasive polishingmaterials that may be used in the present invention, as well as otherabrasives, generally have an average particle size ranging between about0.1 to about 30 μm or from about 5 to about 15 μm. The abrasive can beprecipitated silica or silica gels such as the silica xerogels describedin Pader et al., U.S. Pat. No. 3,538,230 and DiGiulio, U.S. Pat. No.3,862,307. Silica xerogels marketed under the trade name “Syloid” by theW.R. Grace & Company, Davison Chemical Division, Augusta, Ga. may beused. Also precipitated silica materials such as those marketed by theJ. M. Huber Corporation, Edison, N.J. under the trade name, “Zeodent”,particularly the silica carrying the designation “Zeodent 119”, may beused. The types of silica dental abrasives useful in the oral carecompositions of the present invention are described in more detail inU.S. Pat. Nos. 4,340,583; 5,589,160; 5,603,920; 5,651,958; 5,658,553;and 5,716,601.

The composition can be substantially free of a silica abrasive.

The abrasive can include polymethyl organosiloxane particles. The typesof polymethyl organosiloxane particles useful in the oral carecompositions of the present invention are described in more detail inU.S. Pat. No. 9,017,647. It may be advantageous to select an abrasivecontaining polymethyl organosiloxane particles because they are lessreactive with ingredients commonly found in oral care compositions,including oral care actives such as peroxide.

The abrasive can include calcium pyrophosphate. The abrasive can includepoly(methyl methacrylate), calcium carbonate, dicalcium phosphate,and/or barium sulfate.

Thickening material or binders may be used to provide a desirableconsistency to the oral care compositions of the present invention.

Thickening materials can include carboxyvinyl polymers, carrageenan,hydroxyethyl cellulose, and water soluble salts of cellulose ethers suchas sodium carboxymethylcellulose and sodium hydroxyethyl cellulose.Natural gums such as gum karaya, xanthan gum, gum arabic, and gumtragacanth can also be used. Colloidal magnesium aluminum silicate orfinely divided silica can be used as part of the thickening material tofurther improve texture. Thickening materials can be used in an amountfrom about 0.1% to about 15%, by weight of the oral care composition.Thickening materials can be used in an amount from about 0.01% to about3%, alternatively from about 0.1% to about 2%, alternatively from about0.2% to about 1%, alternatively from about 0.25% to about 0.75%,alternatively from about 0.27% to about 0.5%, and alternatively fromabout 0.3% to about 0.4%. The oral care compositions can also containbinders that can also adjust formulation texture and mouth feel.

The thickening agent can include the addition of polymers of acrylicacid crosslinked with an unsaturated polyfunctional agent such as apolyallyl ether of sucrose. These carboxy vinyl polymers have the CTFA(Cosmetic, Toiletry and Fragrance Association) adopted name of“carbomer.” A carbomer can include negatively charged polyelectrolytes,such as Carbomer 956 (available from Lubrizol Corporation, Wickliffe,Ohio). The carbomer can be selected from the group consisting ofacrylates/C10-30 alkyl acrylate crosspolymer, sodium polyacrylate;polyacrylate-1 Crosspolymer (available from Lubrizol); polyacrylateCrosspolymer-11 (available from Clariant, Inc., Louisville, Ky., USA),acrylates/C10-30 alkyl acrylate crosspolymer, and combinations thereof.The carbomer can be Carbomer 956. The composition can contain from about0.1% to about 15% carbomer, alternatively from about 0.3% to about 10%carbomer, alternatively from about 0.5% to about 6% carbomer,alternatively from about 0.7% to about 3% carbomer, and alternativelyfrom about 0.9% to about 1.5% carbomer. Examples of additional carbomerscan be found in U.S. Pat. No. 2,798,053.

Humectants keep oral care compositions from hardening upon exposure toair and certain humectants can also impart desirable sweetness of flavorto dentifrice compositions. Suitable humectants for use in the presentinvention include glycerin, sorbitol, polyethylene glycol, propyleneglycol, xylitol, and other edible polyhydric alcohols. The oral carecompositions of the present invention may comprise humectants in anamount of from about 0% to about 70% or from about 15% to about 55%, byweight of the oral care composition.

Brookfield Viscosity Test

The viscometer is Brookfield viscometer, Model ½ RVT, with a Brookfield“Heliopath” stand (available from Brookfield Engineering Laboratories,Middleboro, Mass.). The spindle is a conventional “E-series” T-shapedspindle. The viscometer is placed on the Heliopath stand and leveled viaspirit levels. The E spindle is attached, and the viscometer is set to2.5 RPM while it is running The viscosity is measured after 1 minute andthe temperature is constant at 25° C. The “Brookfield Unit” in whichresults obtained from this method have traditionally been expressed issimply the direct readout of the instrument under standard conditions,i.e., using the “E” spindle at 2.5 RPM, or calculated equivalent.

pH Test Method

First, calibrate the Thermo Scientific Orion 320 pH meter. Do this byturning on the pH meter and waiting for 30 seconds. Then take theelectrode out of the storage solution, rinse the electrode withdistilled water, and carefully wipe the electrode with a scientificcleaning wipe, such as a Kimwipe®. Submerse the electrode in the pH 7buffer and press the calibrate button. Wait until the pH icon stopsflashing and press the calibrate button a second time. Rinse theelectrode with distilled water and carefully wipe the electrode with ascientific cleaning wipe. Then submerse the electrode into the pH 4buffer and wait until the pH icon stops flashing and press the measurebutton. Rinse the electrode with distilled water and carefully wipe witha scientific cleaning wipe. Now the pH meter is calibrated and can beused to test the pH of a solution.

The pH of the liquid medication is measured using the calibrated pHmeter at ambient temperature.

Phase Separation Method

After the toothpaste is made, 25 grams of the composition is placed in apolypropylene speed mix jar (max 40 SpeedMixer™ contain available fromFlackTek™ Inc.) with a screwed lid screwed hand tight. Then, thecontainer is placed in an oven (Espec™ LHV-113 Temperature and HumidityCabinet was used here) at 40° C. for about 8 hours. Then, the containeris removed and it is observed to see if any phase separation wasvisually perceptible.

EXAMPLES

Ex. 1 Ex. 2 Ex. 3 Ex. 4 (wt. %) (wt. %) (wt. %) (wt. %) Water 51.8959.67 53.62 49.59 Lanette ® W¹ 12.00 — — — Cold Dispersible Fatty — 6.0012.00 16.00 Amphiphile² Sodium Lauryl Sulfate 2.50 1.50 1.50 1.50 PowderSepiMAX ™ ZEN 0.60 — — — Hydrogen Peroxide (35% 8.57 8.57 8.57 8.57Ultra Cosmetic) Sodium Fluoride 0.24 — — — Sodium — 0.76 0.76 0.76Monofluorophosphate Sodium Acid 0.500 1.00 1.00 1.00 PyrophosphateDibasic Sodium Phosphate 0.20 0.20 0.25 0.28 USP Sucralose 0.50 0.300.30 0.30 Potassium Nitrate USP 5.00 5.00 5.00 5.00 Tospearl ® 145³15.00 — — — Calcium Pyrophosphate — 15.00 15.00 15.00 Flavor 3.00 2.002.00 2.00 ¹Lanette ® W is mixture (40:40:10) of cetyl alcohol/stearylalcohol/sodium lauryl sulfate and is available from BASF Corp ²The colddispersible fatty amphiphile is 40% cetyl alcohol, 40% stearyl alcohol,10% sodium lauryl sulfate, and 10% sodium acrylate/sodium acryloyldimethyl daurate copolymer. ²Polymethyl organosiloxane particles, morespecifically polymethyl organosiloxane silicone resin particles,available from Momentive ™ Performance Materials, New York

Example 1 was made as follows. A jacketed mix tank was set to 85° C.Water and Lanette® W were added to the vessel with agitation until thetemperature reached 80° C. and a solution that includes melted fattyalcohols and SLS was formed. Then, the polyacrylate crosspolymer-6 wasadded under agitation to form a substantially homogenous mixture. Then,the heating jacket was reset to 25° C. and the batch was cooled. Afterthe mixture cools, the following materials were added to the vessel:hydrogen peroxide, potassium nitrate, sodium fluoride, sodium acidpyrophosphate, dibasic sodium phosphate and sucralose with agitation andhomogenization. Next, the abrasive (Tospearl® 145) was added to thevessel with agitation and the mixture was thoroughly mixed. Once theabrasive had wetted out (i.e. no powders are floating on top of theliquid) the mixture was deaerated. Once the composition wasapproximately homogenous and approximately all of the air was removed,the flavor the remaining SLS were added to the vessel with agitation.The mixture was then deaerated again. Finally, the first bit ofheterogeneous material was removed at the beginning of pumping out ofmix tank into a separate container and was discarded as scrap. Once thematerial began to appear homogeneous, it was collected in a cleancontainer and stored as the final composition. The final composition canthen be used to fill tubes, if desired.

Examples 2, 3, and 4 were made as follows. A jacketed mix tank was setto 30° C. The water and 0.1% SLS were added to the vessel withhomogenization. Then, the cold dispersible fatty amphiphile was addedunder agitation to form a substantially homogenous mixture. Then, thefollowing materials were added to the vessel: hydrogen peroxide,sucralose, sodium monofluorophosphate, dibasic sodium phosphate, sodiumacid pyrophosphate, and potassium nitrate with agitation andhomogenization. Then, the abrasive (calcium pyrophosphate) was added tothe vessel with agitation. Once the abrasive had wetted out, the mixturewas deaerated. Once the composition was approximately homogenous andapproximately all of the air was removed, the remaining SLS, and flavorwas added to the vessel with agitation. The mixture was then deaeratedagain. Next, a sample was removed and the pH was measured. Finally, thefirst bit of heterogeneous material was removed from the container andwas discarded as scrap. Once the material began to appear homogeneous,it was collected in a clean container and stored as the finalcomposition. The final composition can then be used to fill tubes, ifdesired.

Combinations

-   -   A. An oral care composition comprising: (a) a gel network phase        comprising a fatty amphiphile and a secondary surfactant; (b)        potassium nitrate; (c) a peroxide source selected from the group        consisting of hydrogen peroxide, urea peroxide, calcium        peroxide, sodium peroxide, zinc peroxide, polyvinylpyrrolidone        peroxide complex or combinations thereof; (d) from about 2% to        about 25% abrasive, or from about 5% to about 20% abrasive, or        from about 7% to about 18% abrasive, or from about 9% to about        16% abrasive; (e) and a fluoride ion source selected from the        group consisting of stannous fluoride, sodium fluoride,        potassium fluoride, amine fluoride, sodium monofluorophosphate,        indium fluoride, amine fluoride, and combinations thereof;        wherein phase separation is not visually perceptible as        determined by the phase separation method.    -   B. The oral care composition according to paragraph A wherein        the composition comprises from about 0.01% to about 6% peroxide,        or from about 0.05% to about 3% peroxide, or from about 0.1% to        about 1% peroxide.    -   C. The oral care composition according to any one of the        preceeding paragraphs A-B wherein the abrasive is selected from        the group consisting of polyorganosilsequioxane particles,        calcium pyrophosphate, dicalcium phosphosphate, calcium        phosphate, strontium carbonate, barium sulfate, fused silica, or        combinations thereof.    -   D. The oral care composition according any one of the preceding        paragraphs A-C wherein the composition further comprises an AMPS        polymer, co-polymer, and/or crosspolymer wherein the AMPS        polymer, co-polymer, and/or crosspolymer is selected from the        group consisting of hydroxyethyl acrylate/sodium        acryloyldimethyl taurate copolymer, ammonium acryloyldimethyl        taurate/vinyl pyrrolidone copolymer, ammonium        acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer,        sodium acrylate/sodium acryloyldimethyltaurate copolymer,        acrylamide/sodium acryloyldimethyltaurate copolymer,        polyacrylate crosspolymer-6, and combinations thereof.    -   E. The oral care composition any one of the preceding paragraphs        A-D wherein the composition is substantially free of        carrageenan.    -   F. The oral care composition according to any one of the        preceding A-E wherein the composition comprises from about 3% to        about 17% fatty amphiphile, or from about 5% to about 15% fatty        amphiphile, or from about 7% to about 13% fatty amphiphile, or        from about 10% to about 11.5% fatty amphiphile.    -   G. The oral care composition according to any one of the        preceding paragraphs A-F wherein the fatty amphiphile comprises        a fatty alcohol selected from the group consisting of cetyl        alcohol, stearyl alcohol, and combinations thereof.    -   H. The oral care composition according to any one of the        preceding paragraphs A-G wherein the composition has a viscosity        from about 5 BKUs to about 70 BKUs, or from about 10 BKUs to        about 45 BKUs, or from about 15 BKUs to about 35 BKUs, or from        about 18 BKUs to about 30 BKUs.    -   I. The composition according to any one of the preceding        paragraphs A-F wherein the composition further comprises from        about 15% to about 95% water, or from about 25% to about 70%        water, or from about 30% to about 50% water, or from about 32%        to about 45% water.    -   J. The composition according to any one of the preceding        paragraphs A-G wherein the composition can contain from about 1%        to about 15% secondary surfactant, or from about 2% to about 10%        secondary surfactant, or from about 4% to about 8% secondary        surfactant, or from 5% to about 7.5% secondary surfactant.    -   K. An oral care composition comprising: (a) a gel network phase        comprising from about 1% to about 20% cold dispersible fatty        amphiphile, or from about 3% to about 17% cold dispersible fatty        amphiphile, or from about 5% to about 16% cold dispersible fatty        amphiphile; (b) potassium nitrate; (c) a peroxide source        selected from the group consisting of hydrogen peroxide, urea        peroxide, calcium peroxide, sodium peroxide, zinc peroxide,        polyvinylpyrrolidone peroxide complex or combinations        thereof; (d) from about 2% to about 25% abrasive, or from about        5% to about 20% abrasive, or from about 7% to about 18%        abrasive, or from about 9% to about 16% abrasive; (e) and a        fluoride ion source selected from the group consisting of        stannous fluoride, sodium fluoride, potassium fluoride, amine        fluoride, sodium monofluorophosphate, indium fluoride, amine        fluoride, and combinations thereof; wherein the oral care        composition comprises from about 3% to about 17% fatty        amphiphile, or from about 5% to about 15% fatty amphiphile, or        from about 7% to about 13% fatty amphiphile, or from about 10%        to about 11.5% fatty amphiphile; wherein phase separation is not        visually perceptible as determined by the phase separation        method.    -   L. The oral care composition according to paragraph K wherein        the composition comprises from about 0.01% to about 6% peroxide,        or from about 0.05% to about 3% peroxide, or from about 0.1% to        about 1% peroxide.    -   M. The oral care composition according to any one of the        preceeding paragraphs K-L wherein the abrasive is selected from        the group consisting of polyorganosilsequioxane particles,        calcium pyrophosphate, dicalcium phosphosphate, calcium        phosphate, strontium carbonate, barium sulfate, fused silica, or        combinations thereof.    -   N. The oral care composition any one of the preceding paragraphs        K-M wherein the composition is substantially free of        carrageenan.    -   O. The oral dosage form according to any one of the preceding        paragraphs K-N wherein the cold dispersible fatty amphiphile        comprises one or more straight or branched carbon chains from        about C8 to about C25, or from about C12 to about C22.    -   P. The oral care composition any one of the preceding paragraphs        K-O wherein the cold dispersible fatty amphiphile comprises 40%        cetyl alcohol, 40% stearyl alcohol, 10% sodium lauryl sulfate,        and 10% sodium acrylate/sodium acryloyl dimethyl taurate        copolymer.    -   Q. The oral care composition according to paragraph K-P wherein        the fatty amphiphile comprises a fatty alcohol selected from the        group consisting of cetyl alcohol, stearyl alcohol, and        combinations thereof.    -   R. The oral care composition according to any one of the        preceding paragraphs K-Q wherein the cold dispersible fatty        amphiphile comprises: (a) a fatty amphiphile; (b) a surfactant;        and (c) a 2-acrylamido-2-methylpropane sulfonic acid (AMPS)        polymer; wherein the weight ratio of fatty amphiphile to        surfactant is from about 2:1 to 25:1, or from about 4:1 to about        15:1, or from about 6:1 to about 9:1.

Values disclosed herein as ends of ranges are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each numerical range is intended to meanboth the recited values and any real numbers including integers withinthe range. For example, a range disclosed as “1 to 10” is intended tomean “1, 2, 3, 4, 5, 6, 7, 8, 9, and 10” and a range disclosed as “1 to2” is intended to mean “1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and2.”

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

Every document cited herein, including any cross referenced or relatedpatent or application and any patent application or patent to which thisapplication claims priority or benefit thereof, is hereby incorporatedherein by reference in its entirety unless expressly excluded orotherwise limited. The citation of any document is not an admission thatit is prior art with respect to any invention disclosed or claimedherein or that it alone, or in any combination with any other referenceor references, teaches, suggests or discloses any such invention.Further, to the extent that any meaning or definition of a term in thisdocument conflicts with any meaning or definition of the same term in adocument incorporated by reference, the meaning or definition assignedto that term in this document shall govern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. An oral care composition comprising: a. a gelnetwork phase comprising a fatty amphiphile and a secondary surfactant;b. potassium nitrate; c. a peroxide source selected from the groupconsisting of hydrogen peroxide, urea peroxide, calcium peroxide, sodiumperoxide, zinc peroxide, polyvinylpyrrolidone peroxide complex orcombinations thereof; d. an abrasive; e. a fluoride ion source selectedfrom the group consisting of stannous fluoride, sodium fluoride,potassium fluoride, amine fluoride, sodium monofluorophosphate, indiumfluoride, amine fluoride, and combinations thereof; wherein phaseseparation is not visually perceptible as determined by the phaseseparation method.
 2. The oral care composition of claim 1 wherein thecomposition comprises from about 0.1% to about 8% peroxide.
 3. The oralcare composition of claim 1 wherein the abrasive is selected from thegroup consisting of polyorganosilsequioxane particles, calciumpyrophosphate, dicalcium phosphosphate, calcium phosphate, strontiumcarbonate, barium sulfate, fused silica, or combinations thereof.
 4. Theoral care composition of claim 1 wherein the composition furthercomprises an AMPS polymer, co-polymer, and/or crosspolymer wherein theAMPS polymer, co-polymer.
 5. The oral care composition of claim 1wherein the composition is substantially free of carrageenan.
 6. Theoral care composition of claim 1 wherein the composition comprises fromabout 3% to about 17% fatty amphiphile.
 7. The oral care compositionaccording to claim 1 wherein the fatty amphiphile comprises a fattyalcohol selected from the group consisting of cetyl alcohol, stearylalcohol, and combinations thereof.
 8. The oral care compositionaccording to claim 1 wherein the composition has a viscosity from about10 BKUs to about 45 BKUs.
 9. The oral care composition according toclaim 1 wherein the composition further comprises from about 25% toabout 70% water.
 10. The composition according claim 1 wherein thecomposition comprises from about 1% to about 15% secondary surfactant.11. An oral care composition comprising: a. a gel network phasecomprising a cold dispersible fatty amphiphile; b. potassium nitrate; c.a peroxide source selected from the group consisting of hydrogenperoxide, urea peroxide, calcium peroxide, sodium peroxide, zincperoxide, polyvinylpyrrolidone peroxide complex or combinations thereof;d. an abrasive; and e. a fluoride ion source selected from the groupconsisting of stannous fluoride, sodium fluoride, potassium fluoride,amine fluoride, sodium monofluorophosphate, indium fluoride, aminefluoride, and combinations thereof; wherein the oral care compositioncomprises from about 3% to about 17% fatty amphiphile; and wherein phaseseparation is not visually perceptible as determined by the phaseseparation method.
 12. The oral care composition of claim 11 wherein thecomposition comprises from about 0.01% to about 8% peroxide.
 13. Theoral care composition according to claim 11 wherein the abrasive isselected from the group consisting of polyorganosilsequioxane particles,calcium pyrophosphate, dicalcium phosphosphate, calcium phosphate,strontium carbonate, barium sulfate, fused silica, or combinationsthereof.
 14. The oral dosage form according to claim 11 wherein the colddispersible fatty amphiphile comprises one or more straight or branchedcarbon chains from about C8 to about C25.
 15. The oral care compositionof claim 11 wherein the cold dispersible fatty amphiphile comprises 40%cetyl alcohol, 40% stearyl alcohol, 10% sodium lauryl sulfate, and 10%sodium acrylate/sodium acryloyl dimethyl taurate copolymer.
 16. The oralcare composition of claim 11 wherein the fatty amphiphile comprises afatty alcohol selected from the group consisting of cetyl alcohol,stearyl alcohol, and combinations thereof.
 17. The oral care compositionaccording to claim 11 wherein the cold dispersible fatty amphiphilecomprises: a. a fatty amphiphile; b. a surfactant; and c. a2-acrylamido-2-methylpropane sulfonic acid (AMPS) polymer; wherein aweight ratio of fatty amphiphile to surfactant is from about 2:1 to25:1.
 18. The oral care composition of claim 17 wherein the weight ratioof fatty amphiphile to surfactant is from about 4:1 to about 15:1. 19.The oral care composition of claim 17 wherein the weight ratio of fattyamphiphile to surfactant is from about 6:1 to about 9:1.